MIDD for dose confirmation in special populations: full covariate modeling meets intersection-union testing

Presented at the International Symposium on Biopharmaceutical Statistics, March 2024. From basic dose adjustments to more ambitious programs for personalized medicine, pharmacometrics has a long tradition of informing tailored treatment strategies. Many of the modeling strategies are well-precedented, but formal decision frameworks are needed to address the question: how much data is enough to support a decision?